Interrupting HAART during limited periods of time ("structured treatment interruption : STI") could entail benefits (better long term tolerance, lower drug-induced viral resistance, lower cost) but also concomitant risks (lower efficacy, higher drug-induced viral resistance). At present, the benefit/risk ratio of STI is unclear. Several STI trials are in progress in industrialised countries. This trial aim at assessing the benefits and risks of two different STI strategies in West Africa.

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:

To assess the non-inferiority at 24 months of two STI strategies of HAART compared with a continuous HAART in terms of :

Percentage of patients with CD4 count over 350 per mm3

Incidence of severe morbidity

Incidence of mortality

Secondary Outcome Measures:

To compare at 24 months two STI strategies of HAART with a continuous HAART in terms of :

HIV resistance to antiretroviral drugs

Cost-utility

Compliance to treatment

Enrollment:

840

Study Start Date:

December 2002

Study Completion Date:

December 2006

Detailed Description:

The objective of this study is to assess the non-inferiority of two strategies of structured treatment interruption (STI) of highly active antiretroviral treatment (HAART) compared with a continuous HAART.

It's a multicentric open labeled randomised non-inferiority trial, which takes place in 5 health care centres in Abidjan, the economic capital city of Cote d'Ivoire

preferably efavirenz, for HIV-1 infected men, and HIV-1 infected women with an effective contraception and no history of nevirapine-containing p-MTCT (prevention of mother to child transmission);

ritonavir-indinavir, for HIV-2 infected patients, women not desiring contraception, and women with a past history of p-MTCT with nevirapine.

Trial phase : After at least six months on continuous HAART in the pre-randomisation phase, patients who meet success criteria (CD4 count over 350/mm3, undetectable viral load, absence of current opportunistic infection) are randomised into three arms :

Arm 3: CD4-guided STI strategy (2 of 6 patients): unlimited interruption of HAART, and then re-introduction/re-interruption guided by the evolution of the CD4 count.

Following the DSMB recommendation, the arm 3 has been discontinued in october 2005. The trial is continuing for patients in the arms 1 and 2.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Informed consent

18 years old or more

CD4 count between 150 and 350 per mm3 (or CD4 percentage between 12.5 and 20 percent)

no past history of curative antiretroviral therapy

residence in Abidjan

Exclusion Criteria:

pregnancy

severe renal failure

severe hepatic failure

severe neuropsychiatric disease

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158405

Locations

Côte D'Ivoire

Centre de Prise en Charge et de Formation ACONDA

Abidjan, Côte D'Ivoire

Centre de Suivi des donneurs de sang, Centre National de Transfusion Sanguine